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BAF_FRontier-1

LY4152199 for B-cell Malignancies After Prior Treatment

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What is being tested

LY4152199 - IV

Drug
Who is being recruted

Hemic and Lymphatic Diseases
+9

+ Immune System Diseases
+ Immunoproliferative Disorders
Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2026
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2026Actual date on which the first participant was enrolled.

This study is focused on evaluating a new medication called LY4152199 for adults who have previously been treated for B-cell lymphoma or leukemia. These are types of blood cancers that affect the B-cells, a kind of white blood cell. The goal is to assess how safe the drug is and how well it works in treating these cancers, especially for those who haven't found success with other treatments. Understanding the effects of LY4152199 could offer new hope and treatment options for patients facing these challenging conditions. The study involves two main parts. Initially, participants will help determine the best dose of LY4152199, ensuring it is both safe and potentially effective. In this phase, researchers will monitor participants closely for any side effects. Once the optimal dose is identified, the second part of the study will evaluate how well this dose works in treating specific types of B-cell cancers and leukemia. Participants will receive the drug and undergo regular health checks to see how their cancer responds to the treatment, providing essential data on its potential benefits and risks.

Official TitleBAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies 
NCT07101328
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
215 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hemic and Lymphatic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Criteria
16 inclusion criteria required to participate
Cohort C3: Mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), WM that has relapsed after or failed to respond to prior systemic treatment regimen.
Cohort C4: Chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) that has relapsed after or failed to respond to prior systemic treatment regimen.
Must have histologically confirmed diagnosis of relapsed/refractory B-cell malignancies as defined below per specific cohort.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

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15 exclusion criteria prevent from participating
Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.
Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.
Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.
Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Escalating doses of LY4152199 administered intravenously (IV)

Administered by IV infusion
Group II
Experimental
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Administered by IV infusion
Group III
Experimental
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Administered by IV infusion
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 50 locations
Suspended
City of HopeDuarte, United StatesSee the location
Suspended
University of Colorado Denver - School of Medicine - Anschutz Medical CampusAurora, United States
Suspended
Colorado Blood Cancer InstituteDenver, United States
Suspended
Yale University School of Medicine - Yale Cancer CenterNew Haven, United States
Recruiting soon50 Study Centers
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